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Enhancing Phase I Clinical Decision Making Through the Use of Quantitative Systems Pharmacology Modeling: A Case Study of Mosunetuzumab in Relapsed/Refractory Non-Hodgkin’s Lymphoma

Chi-Chung Li, Ph.D., Senior Scientist, Clinical Pharmacology, Genentech, Roche, South San Francisco.

T cell-engaging bispecific antibodies (T-BsAb) are becoming important molecular entities in the development of immune-oncology agents. The promises in clinical efficacy with the potent mechanism of action comes with the consideration to mitigate potential acute toxicity concerns, driven by the systemic cytokine release following T cell activation.

To aid in the clinical development and maximize the potential therapeutic benefits of mosunetuzumab, an anti-CD20/CD3 T-BsAb, a QSP model was built based on preclinical and literature data and used to simulate and compare the systemic cytokine profiles following various dosing regimens of mosunetuzumab. Results indicate that a step-fractionated dosing regimen may mitigate the peak cytokine release levels and thereby allowing further dose escalation of mosunetuzumab in Phase I development.

The QSP modeling efforts enhanced the design rationale of the Phase 1 clinical studies and was used to enable a successful regulatory interaction with the FDA on protocol amendments. The presentation will touch on factors that are important for the successful clinical impact of modeling by focusing on the appropriate clinical questions and context.

 

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